treatment response adapted hybrid radiotherapy in metastatic non-small cell lung cancer receiving first-line immunotherapy

Conditions: NSCLC Stage IV

Summary: this study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (ldrt and sbrt) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative nsclc, and to provide new ideas for the comprehensive treatment of advanced nsclc


Eligibility criteria:
inclusion criteria: * ecog functional status score was 0-1. * histologically confirmed stage iv primary nsclc; * genetic testing showed that the common driver genes including egfr, alk and ros-1 were negative; * patients with brain metastases were eligible if they were neurologically asymptomatic and had stable disease without receiving systemic glucocorticoids; * according to the investigator's judgment, the patient does not need to receive palliative radiotherapy for any site at present; * male/female of childbearing age agreed to use contraception (surgical ligation or oral contraceptive/intrauterine device plus condom) during the trial; * life expectancy ≥3 months; * one week before enrollment, the organ function level met the following criteria: ① bone marrow function: hemoglobin ≥80g/l, white blood cell count ≥4.0\*10\^9/l or neutrophil count ≥1.5\*10\^9/l, platelet count ≥100\*10\^9/l; ② liver: serum total bilirubin level ≤1.5 times upper limit of normal, direct bilirubin level must be ≤1.5 times upper limit of normal, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤2.5 times upper limit of normal; ③ kidney: serum creatinine \< 1.5 times upper limit of normal or creatinine clearance ≥50ml/min, urea nitrogen ≤200mg/l; serum albumin ≥30g/l; * patients must be able to understand and voluntarily sign the informed consent form. exclusion criteria: * the patient had severe autoimmune diseases: active inflammatory bowel disease (including crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as wegener's granulomatosis), etc. * symptomatic interstitial lung disease or active infectious/non-infectious pneumonia; * patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (gi) obstruction, abdominal cancer, or other known risk factors for intestinal perforation; * history of other malignant tumors; * patients with active infection, heart failure, myocardial infarction, unstable angina or unstable arrhythmia within the past 6 months; * medical examination or clinical findings, or other uncontrollable conditions that the investigator considers may interfere with the results or increase the patient's risk of treatment complications; * patients who were considered by the investigator to have lesions requiring palliative and subtractive radiotherapy; * mixed with small cell lung cancer components; * lactating or pregnant women; * congenital or acquired immunodeficiency diseases including human immunodeficiency virus (hiv), organ transplantation or allogeneic stem cell transplantation; * known hbv, hcv, active pulmonary tuberculosis infection; * patients had received a cancer vaccine or received another vaccine within 4 weeks before starting treatment (note: injectable seasonal influenza vaccine is usually inactivated, so vaccination is allowed, while intranasal vaccine is usually live attenuated, so it is not allowed); * patients with concurrent use of other immune agents, chemotherapy drugs, drugs in other clinical studies, and long-term use of cortisol were excluded. * patients with mental disorders, substance abuse, or social problems that affect adherence were excluded from the study after physician review; * patients who are allergic to or contraindicated to pd-1 monoclonal antibody or chemotherapy drugs.